Scholar Rock says it has made further regulatory progress for apitegromab, its investigational treatment for spinal muscular atrophy.
House Select Committee on China chairman John Moolenaar (R-MI) and Rep. Ben Cline (R-VA) are urging FDA intensify safeguards on clinical trial data ge...
CBER updates its standard operating procedures for resolving scientific/procedural disputes between sponsors and the Center, establishing revised proc...
FDA warns Dayton, NJ-based Safrel Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.
FDA warns Gilbert, AZ-based Suretec Innovations about CGMP and drug listing violations in its manufacturing of finished drugs.
FDA issues a complete response letter to Xspray Pharmas NDA for Dasynoc, raising issues about a third-party manufacturer.
FDA grants Ultragenyx Pharmaceutical accelerated approval for its Genglycos (pariglasgene brecaparvovec-opnr) for adults and children eight years and ...
Senate confirmation of FDA commissioner nominee Heidi Overton appears to be getting some resistance and a quick Senate confirmation seems unlikely.
